AOAC SPADA Meeting

3/11/2020

GLOSSARY (CONT.)

• Inclusivity panel- A panel of strains of the intended PCR assay target organism. Ideally, the assay is expected to be positive for all the panel strains [exceptions i.e., false negatives) are expected] and need to be captured and ideally includes members of its entire genetic diversity • Exclusivity panel- A panel of near neighbors that are expected to be negative for the assay [exceptions i.e., false positives are expected] and need to be captured • Background panel – A panel of organisms found in the matrix of the assay. (e.g. human genome, human microbiome, soil microbes, etc.) • Assay Improvement- Any improvement of existing assays in response to a variety of outcomes from initial testing or field testing. E.g., signature erosion, failure of assays in certain conditions or specific matrices, or in multiplex formats

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GLOSSARY (CONT.)

• Signature Erosion • Emergence of mutations in the sequences of the assay target regions that may lead to assay failure; this may happen due to natural course of evolution especially in virus due to genetic drift or shift or deliberate acts • Reference Materials • Assay template materials used in development, testing, validation, test and evaluation of the assay; e.g., live organisms, inactivated organisms, genomic materials (DNA or RNA), synthetic plasmids, or even synthetic amplicons • Assay Performance (LoD) • Establishing LoD in various matrices • Advance development • Entails validating the assay performance for specific use scenarios

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